The detection of abnormal cell growth in the cervix is important for detecting a number of disease conditions from precancerous atypical dysplasia to invasive cancer. This procedure begins by first obtaining a pap smear of the area. If the pap smear is positive, or abnormal, a physician usually examines the patient further. The physician typically uses a magnifying colposcope to identify and examine suspicious areas in the transitional zone and takes biopsies of these areas with the aid of a colposcope. Alternately, if the upper areas of the cervix at or beyond the internal os are involved, the physician will typically take a blind biopsy using a device such as a Cell Sweep.RTM. (described in detail in U.S. Pat. No. 5,002,408 and U.S. Pat. No. De 335,706 to Mohajer) and using a curette to make an endocervical curettage (ECC) around the entire area.
The cervix presents problems for the physician, particularly in the area up to the anatomical internal os. This is an area that it is difficult for the physician to observe directly even with the aid of instruments. It follows therefore that biopsy sampling and curettage is problematic. The ECC procedure is very important. Approximately 14% of lesions picked up by a pap smear occur up to the internal os area, beyond the area seen in a colposcopic examination.
Endometrial tissue sampling devices for securing and removing endometrial tissue are typically terminated at the distal end by a scraping member. Some kind of suction is usually included with the sampling device or some kind of suction probe inserted into the uterus following scraping to gather loosened tissue.
U.S. Pat. No. 3,777,643 to Binard et al, describes an endometrial sampler comprising a rigid hollow tube having a sampling end with a plurality of sampling ports communicating with the interior of the tube. Essentially, the sampler is a flexible plastic rod with a stainless steel probe that is manipulated with a syringe to gather fluid samples from the uterus. The probe does not have a cutting port.
U.S. Pat. No. 4,340,066 to Shah describes an instrument having a longitudinal chamber with a slot and a transverse slot. The handle is connected to a syringe and the physcian uses the entire probe to scrape and gather tissue samples.
U.S. Pat. No. 4,393,879 to Milgrom discloses a curette with a tissue-scraping device such as a spoon at one end. The handle member is operated by utilizing both hands to produce a sucking action to collect the tissue samples.
U.S. Pat. No. 4,396,022 to Marx describes an endometrial tissue sampling apparatus that includes a probe made of stainless steel for scraping and removing endometrial tissue. The probe is covered in a sheath. The user inserts the probe into the endometrial cavity and begins blindly scraping and cutting tissue samples. A syringe is attached to the sheath, and it is utilized to create a vacuum so the tissue samples can be sucked into the shaft and then into the syringe.
U.S. Pat. No. 4,627,444 to Booker describes a device for sampling tissues and fluids from body cavities. This device has a tube within a tube, with a retrieval line, multiple cutting edges, a protective sleeve, a stop sleeve, a plug and a cap. The catheter has integral parts and appears to be a rather difficult instrument to use. After insertion, the protective cap or tip is dislodged into the patient and the probe or curette includes a plurality of notches for blindly scraping tissue samples from the cavity walls. A syringe is attached and provides suction to collect the scraped tissue samples.
The devices described in the above references illustrate a variety of approaches to retrieving endometrial tissue samples. However, all of these devices are relatively complicated and fall short of attaining the most accurate sample possible.
In addition, every cervix differs in size according to a number of factors such as age and the number of births. The insertion of prior art ECC devices typically involve dilating the cervix using a separate dilator. This procedure can vary from uncomfortable to painful. Frequently the dilator used must be larger than the ECC device because the dilator must be removed and the ECC inserted. The time involved obviously increases the period of time discomfort or pain must be endured by the patient.
For some women the pain is significant enough that they refuse an ECC despite the risk of missing an invasive cervical cancer. The results of this can be fatal. and radiation therapy or radical surgery, even if successful in stopping the cancer, can still result in loss of sexual function and fertility.